Ketones Influence on Glucose Metabolism in Brain. A Human Positron Emission Tomography (PET) Study

Not Applicable

Completed

• Conditions: Ketone Body Metabolism; Brain Metabolism
• Interventions: Drug: placebo; Drug: ketone

• Registration Number: NCT02357550
• Lead Sponsor: University of Aarhus

Brief Summary

This project tend to investigate the affection of ketone bodies on brain metabolism. This will be done by measuring human cerebral uptake of energy substrates, together with functional parameters, using PET imaging and appropriate radiotracers under hyperketonemia in healthy subjects by ketone infusion.

Hypotheses

1. Increased levels of ketone bodies in healthy subjects leads to decreased glucose uptake by brain cells contributing to hyperglycaemia.

2. Increased levels of ketone bodies in healthy subjects leads to increased cerebral blood flow.

3. Altered oxygen consumption during hyperketonemia in healthy subjects.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-01
• Study First Submitted: 2015-01-26
• Study First Submitted QC: 2015-02-02
• Study First Posted: 2015-02-06
• Study Start: 2015-03
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Last Update Submitted: 2016-01-15
• Last Update Posted: 2016-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

• Healthy
• BMI 20-30 kg/m2

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Exclusion Criteria

• smoking
• alcohol abuse
• severe comorbidity
• blood donation 6 month prior
• claustrophobia

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Control	placebo	Saline infusion. FDG-PET Scan. O2-PET scan. H2O-PET scan Muscle biopsy
Hyperketonaemia	ketone	Ketone infusion. FDG-PET Scan. O2-PET scan. H2O-PET scan Muscle biopsy

Primary Outcome Measures

Name	Time	Method
Glucose metabolism in brain, CMR	t=240-360 minutes	cerebral glucose metabolism measured by PET tracer during the above time frame

Secondary Outcome Measures

Name	Time	Method
Stress metabolism	0-360 minutes	growth hormone, cortisol, glucagon, adrenalin, ghrelin.
Oxygen use	T=150-200 minutes	cerebral oxygen consumption measured by PET tracer during the above time frame
cerebral blood flow	t=180-250 minutes	cerebral blood flow measured by PET tracer during the above time frame
Intramuscular signaling	t= 260 minutes	protein and insulin signaling in muscle

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark